Summary
Overview
Work History
Education
Skills
Publications
Therapeutic Experience
Timeline
Generic

Young-Sil (Anna) Yim

Mount Airy,MD

Summary

Executive Director with extensive experience at Elevar Therapeutics, specializing in regulatory submissions and strategic planning. Demonstrated success in expediting product approvals and addressing critical regulatory challenges. Expertise in client relationship management and risk assessment, contributing to successful drug development outcomes.

Overview

27
27
years of professional experience

Work History

Exeutive Director, Regulatory Affairs

Elevar Therapeutics, Inc.
06.2024 - Current
  • Liaised with global regulatory authorities to resolve key issues and expedite product approvals.
  • Managed critical regulatory issues, providing leadership in regulatory contributions.
  • Collaborated with R&D, Quality Assurance, Legal, and Marketing to integrate regulatory considerations into product development.
  • Reviewed and authored IND/CTA, NDA/MAA sections and other submission documents for clinical trials.
  • Oversaw preparation and submission of documentation for investigational and marketing registration packages globally, ensuring adherence to timelines.

Senior Director, Regulatory Affairs

Allucent (formerly CATO SMS)
Cary, US
01.2022 - 06.2024
  • Reviews and / or writes regulatory / scientific documents or sections thereof, with efficiency, accuracy and independent thought.
  • Contributes significantly to strategic/regulatory discussions and associated documents/reports regarding drug, biologic, or device development.
  • Guides the writing of regulatory/scientific documents written by other project team members.
  • Reviews, edits and guides the writing of HA meeting requests and briefing documents. Leads HA meetings as Regulatory SME.
  • Provides strategic advice and translates regulatory requirements into practical plans and solutions.
  • Evaluates change impact and necessary HA reporting requirements and strategies for drug products or devices from development through post-approval management.
  • Has advanced knowledge of CTD format and structure for regulatory submissions.
  • Contributes to Due Diligence Reviews / reports.
  • Actively supports staff learning & development within the company and provides guidance and advises Project Leads, and/or Project Teams.
  • Actively manages, develops, and strengthens client relationships, drives repeat business.

Principal Consultant

Parexel International
Billerica, US
01.2020 - 01.2022
  • Provided strategic input, facilitate storyboarding meetings, and provides technical guidance on regulatory requirements as the regulatory project lead, managing IND and NDA submissions.
  • Established working relationships and interfaces with clients, internal stakeholders as well as health authorities.
  • Led cross-functional teams and aligns resources to discuss and resolve regulatory issues to ensure project tasks are completed as well as during interactions with regulatory authorities.
  • Acted as a loaned executive for clients and facilitates resolutions to possible problems or conflicts within the project team and/or the client.
  • Proactively managed and monitored regulatory submission project progress.
  • Ensured that appropriate risk identification and issue-escalation procedures are in place as well as leads issue and conflict resolutions.
  • Worked closely with peers, CMC, Nonclinical and Clinical experts and the broader Parexel talent pool to address regulatory questions and provide guidance on submissions/HA interactions.

Associate Regulatory Program Director

Parexel International
Bethesda, US
01.2019 - 01.2020
  • Ensured consistency across projects in program, provide oversight to a Regulatory Project Lead (PL) team, manage senior stakeholders internally and externally, maintain appropriate level of oversight and ensuring accountability is retained within each project by the PL.
  • Responsible for project planning, set-up and routine interactions with the assigned Project Specialist (PS) or Project Manager (PM) to appropriately control the project (e.g. project set-up, forecasting and financial entries, invoicing, etc.). Manages project financials including provision of accurate revenue forecasts.
  • Served as the main client contact, ensures accurate project reporting is in place and that the project team delivers to meet the client expectations for quality and timeliness. Provide mentoring to Project Leads where appropriate.
  • Acted as senior point of escalation for issues, arranges for follow through of resolutions via the appropriate departments, ensures that appropriate risk identification and issue-escalation procedures are in place and leads issue and conflict resolutions.
  • Established team goals and structure for program with senior leadership/client, inspire individual ownership and accountability to achieve high client satisfaction and successful study completion.

Senior Regulatory Project Lead

Parexel International
Bethesda, US
01.2018 - 01.2019
  • Managed the overall drug development activities such as drug application review, reporting and created timelines for numerous products at different stages of development. Managed and provided resolutions to scientific and regulatory risks in order to achieve target goals.
  • Responsible for timely completion of the project activities, achieving project objects and goals set by the team and the client. Managed project activities including the overall project plan, team members and identified potential impact and recommended solutions. Provided regulatory guidance to facilitate project planning to ensure objective is met in agreed timeline.
  • Managed and ensured Agency submission documentations are drafted/finalized with high quality (Agency Meeting documents, IND, NDA, BLA). Managed and facilitated the gap analysis, clinical development plan, US FDA milestone (PDUFA, BsUFA) meetings.

Regulatory Affairs Manager

Parexel International
Bethesda, US
01.2016 - 01.2017
  • Managed the overall drug development activities such as drug application review, reporting and created timelines for numerous products at different stages of development.
  • Managed and provided resolutions to scientific and regulatory risks in order to achieve target goals.
  • Responsible for timely completion of the project activities, achieving project objects and goals set by the team and the client.
  • Managed project activities including the overall project plan, team members and identified potential impact and recommended solutions.
  • Provided regulatory guidance to facilitate project planning to ensure objective is met in agreed timeline.

Senior Regulatory Affairs Consultant

Parexel International
Bethesda, US
01.2014 - 01.2016
  • Managed the overall drug development activities and timelines for numerous products at different stages of development, including both CMC and clinical support. Managed and facilitated the gap analysis, clinical development plan, US FDA milestone (PDUFA, BsUFA) meetings.
  • Managed US and ROW marketing authorization applications included co-ordination of support for global development at various stages, from pre-IND through to marketed products. Managed and ensured.
  • Developed and maintained timelines and submission trackers for all FDA submissions.
  • Facilitated roundtable reviews to verify adherence to key messages throughout the NDA documents, confirmed internal and external cohesion of NDA modules. Led team meetings on a regular basis to ensure project objectives are met and ensured.

Regulatory Affairs Consultant

Parexel International
Bethesda, US
01.2011 - 01.2014
  • Provided support for preparation of Rx to OTC switch application for submission to FDA.
  • Managed APAC region-based client’s first NDA approval, and responsible for leadership of project team from NDA submission through to approval.
  • Authored, reviewed and compiled regulatory documents for inclusion in Agency meeting background packages, INDs, CTAs, and NDAs.
  • Facilitated formal meetings with FDA, including communications with FDA project managers, management of rehearsals, participation in meetings and preparation and submission of meeting minutes.

Senior Regulatory Affairs Associate

GenVec, Inc.
Gaithersburg, US
01.2008 - 01.2011
  • Managed the daily activities of Investigational New Drug (IND) applications for gene therapy products (Phases 1 through 3): submitted serial submissions, reviewed clinical protocols and amendments, drafted annual reports, compiled safety report submissions, reviewed final clinical study reports.
  • Maintained the Chemistry, Manufacturing and Controls (CMC) section for gene therapy and vaccine products through the preparation and review of amendments to the INDs. Maintained and prepared Type II biologic Master Files (MF) submissions/amendments and annual reports. Maintained submission trend analysis and safety database.
  • Submitted regulatory documents to NIH’s Office of Biotechnology Activities (OBA) for review by the Recombinant DNA Advisory Committee (RAC). Interfaced with NIH OBA directly, facilitating response to safety queries.
  • Reviewed quality system procedures (SOPs, validation protocol/reports, stability protocol/amendments, change controls, and comparability reports) for accuracy and compliance with regulations.

Research Associate I, II

MedImmune
Gaithersburg, US
01.2000 - 01.2008
  • Developed and validated analytical methods. Generated, executed, and reviewed SOP’s.
  • Compiled documentations for investigations, submissions and used EDMS systems to input, correct documents. Maintained Certificate of Analysis, trend analysis, and validation of equipment.
  • Provided structural characterization of humanized monoclonal antibodies and other vaccine product.
  • Performed routine characterization lot release testing for a licensed product: Peptide mapping using LC-ESI/MS (validated use of ES/MS) and LC-ESI/MS/MS, Mass determination using MALDI-TOF/MS.
  • N-linked oligosaccharide profiling using HPAE-PAD, Ion Exchange Chromatography method for analysis of C-terminal Lysine Variants (optimized method), Monosaccharide composition analysis by RP-HPLC with fluorescence detection, and Mannitol identification and quantitation using HPAE-PAD.

Research Associate I

AMA Analytical Services, Inc.
Lanham, US
01.1999 - 01.2000
  • Monthly quality control validations under SOP conditions. Analysis of lead by Flame Atomic Absorption and Graphite furnace atomic absorption. Analysis of asbestos in air by Phase Contrast Microscopy and bulk samples by Polarized Light Microscopy.

Education

QA/RA Program -

Kriger Research Center Inc.
CA
01.2008

B.S. - Chemistry

University of Maryland
College Park, MD, US
01.1998

Skills

  • Regulatory submissions
  • Project management
  • Strategic planning
  • Risk assessment
  • Client relationship management
  • Drug development

Publications

  • Bowers, A.; Yim, A, Storyboarding as best practice for marketing applications., Regulatory Rapporteur, 18, 7/8, 07/01/21
  • Wei, Z., Tous, G., Yim, A., Hope, J., Casas-Finet, J., Wasserman, G., and Schenerman, M, Validation of peptide mapping with electrospray mass spectrometry for recombinant proteins of biopharmaceutical interests and its application as an identity test and characterization tool, Dev Biol (Basel), 122, 29-47, 01/01/05
  • Holland, C., Kletke, C., Yim, A., Wang, Y., Hope, J., Casas-Finet, J., Schenerman, M, Validation of Tryptic Peptide Mapping with Electrospray Mass Spectrometry of Synagis, a Therapeutic Monoclonal Antibody., WCBP 2002, 01/01/02

Therapeutic Experience

  • New Drug Application (Phase II/III), hepatocellular carcinoma (HCC), cholangiocarcinoma (CCA), non-small cell lung cancer (NSCLC), gastric acid related disorders, multidrug-resistant tuberculosis, metastatic breast cancer (MBC), osteoporosis, necrotizing soft tissue infections (NSTI), primary biliary cholangitis (PBC)
  • Pre-IND and Investigational New Drug (Phase 1/II), solid tumors harboring FGFR2 f/r, crohn’s disease, ulcerative colitis, rheumatoid arthritis, ankylosing spondylitis, plaque psoriasis, alzheimer’s disease, huntington’s disease, myotrophic lateral sclerosis (ALS), parkinson’s disease, duchenne muscular dystrophy (DMD), women’s health

Timeline

Exeutive Director, Regulatory Affairs

Elevar Therapeutics, Inc.
06.2024 - Current

Senior Director, Regulatory Affairs

Allucent (formerly CATO SMS)
01.2022 - 06.2024

Principal Consultant

Parexel International
01.2020 - 01.2022

Associate Regulatory Program Director

Parexel International
01.2019 - 01.2020

Senior Regulatory Project Lead

Parexel International
01.2018 - 01.2019

Regulatory Affairs Manager

Parexel International
01.2016 - 01.2017

Senior Regulatory Affairs Consultant

Parexel International
01.2014 - 01.2016

Regulatory Affairs Consultant

Parexel International
01.2011 - 01.2014

Senior Regulatory Affairs Associate

GenVec, Inc.
01.2008 - 01.2011

Research Associate I, II

MedImmune
01.2000 - 01.2008

Research Associate I

AMA Analytical Services, Inc.
01.1999 - 01.2000

QA/RA Program -

Kriger Research Center Inc.

B.S. - Chemistry

University of Maryland

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